URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)

Enzyme Immunoassay, Opiates

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Urine Heroin/morphine Direct Ria Kit (i-125).

Pre-market Notification Details

Device IDK913863
510k NumberK913863
Device Name:URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
ClassificationEnzyme Immunoassay, Opiates
Applicant Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
ContactJames R Soares
CorrespondentJames R Soares
Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-27
Decision Date1991-09-19

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